Status:
COMPLETED
The Use of Cilostazol in Patients With Diabetic Nephropathy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Diabetes Mellitus, Type 2
Diabetes Complications
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
Brief Summary
Patients with type 2 diabetes have a long duration of disease for the development of complications. Among all complications, microangiopathic complications are major causes of mortality and morbidity ...
Detailed Description
Hypothesis: Cilostazol reduces the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment secondary to diabetic nephropathy. Objectives: To...
Eligibility Criteria
Inclusion
- Male or female patients aged between 20 and 70 years
- Patients with Type 2 diabetic mellitus
- A fasting urinary albumin/creatinine ratio greater than or equal to 30 mg/mmol or 24 hour urinary albumin excretion greater than or equal to 300 mg/day in two urine collections during the baseline period
- Two consecutive serum creatinine levels during baseline period which meet the following requirements:
- Women: between 80 umol/l and 250 umol/l (inclusive)
- Men: between 105 umol/l and 250 umol/l (inclusive)
- Written informed consent
Exclusion
- Pregnancy
- Known allergy to cilostazol or aspirin
- Congestive heart failure (NYHA class III to IV)
- Severe liver impairment (greater than or equal to 3 times ULN of ALT)
- Serum potassium levels greater than or equal to 5.5 mmol/l on 2 consecutive specimens
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00272831
Start Date
December 1 2005
End Date
December 1 2007
Last Update
May 22 2009
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